Eyelid Care Appliance

ABSTRACT

Disclosed herein is an improved eyelid care appliance and method of using such appliance for preventing and treating blepharitis and mammalian meibomian gland dysfunction caused by gland obstruction. The method and apparatus of the invention enable restoration and maintenance of eyelid hygiene and the natural flow of secretions from the meibomian glands. A preferred embodiment of the apparatus comprises an oscillating spongehead affixed to the distal end of the eyelid care appliance that is equipped with a video camera, near field communications link, and a display, thereby enabling a user to “fly” the spongehead onto an eyelid margin for self-administered cleaning of the user&#39;s eyelid margins. The spongehead can be impregnated with topical pharmacologic or cleansing agents to better facilitate cleaning and therapeutic efficacy.

RELATED APPLICATIONS

This application claims the benefit under 35 U.S.C. §119(e) of U.S.Provisional Application No. 61/922,791 filed 31 Dec. 2013 and U.S.Provisional Application No. 62/021,1591 filed 13 Jun. 2014.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention relates to a new and improved method and apparatus toclean debris from eyelids, to treat blepharitis, and to preventmeibomian gland obstruction, which method and apparatus permitself-administered eyelid cleaning and treatment.

2. Description of Related Art

“Dry eye” is the world's most common eye disease. “Dry eye” indicatesthe lack of quantity and/or quality of the tear film. In the human eye,the tear film covering the ocular surfaces is composed of three layers.The innermost layer in contact with the ocular surface is the mucuslayer, comprised of many mucins. The middle layer, comprising the bulkof the tear film, is the aqueous (water) layer, and the outermost layeris a thin (less than 250 nm) layer (“lipid layer”) comprised of manylipids. The typical upper eyelid has about 25 meibomian glands and thelower eyelid has about 20 meibomian glands. The meibomian gland orificesopen onto the eyelid margin at and around the junction of the innermucous membrane and the outer skin of the eyelids; that junction istermed the mucocutaneous junction.

The upward phase of blinking causes the upper eyelid to pull a sheet ofthe lipids secreted by the meibomian glands upward and over the othertwo layers of the tear film, thus forming a type of protective coatingwhich limits the rate at which the underlying layers evaporate. Thus, adefective lipid layer or an incorrect quantity of such lipids can resultin accelerated evaporation of the aqueous layer which, in turn, causessymptoms such as itchiness, burning, irritation, and dryness, which arecollectively referred to as “dry eye”. When left untreated, theconsequences of dry eye can be severe, and even result in loss of vision(e.g., from desiccation of the corneal epithelium, ulceration andperforation of the cornea, or an increased incidence of infectiousdisease).

Dry eye states have many etiologies. A common cause of dry eye states isa disorder in which the glands are obstructed or occluded, usuallyreferred to as “meibomian gland dysfunction” (“MGD”). Meibomian glanddysfunction is frequently the result of keratotic obstructions whichpartially or completely block the meibomian gland orifices. Suchobstructions compromise the secretory functions of the individualmeibomian glands. More particularly, these keratotic obstructions cancomprise combinations of bacteria, sebaceous ground substance, deadcells, and/or desquamated epithelial cells.

Additional causes of the dysfunction of the lipid layer are associatedwith eyelid margin inflammation (e.g., anterior and posteriorblepharitis, hordeolum, sty, chalazion, and rosacea). The etiologicalfactors of many of these inflammations include an overgrowth of bacteria(and/or parasites) and their toxic waste. These bacteria not only causethe lipid tear film to dysfunction, but they also destroy and block thevery lipid-producing infrastructure by attacking the glands in theeyelid skin. Unfortunately, the particular types of bacteria andparasites that cause the inflammation/infections are common. The chanceof having these on the eyelids is nearly 100%. In themselves, they arenot dangerous, but it is the overgrowth and their toxic waste on theeyelid margin and the eyelashes that must be avoided. Allowing thebacteria and parasites to proliferate must be prevented, especially ifone is diagnosed as a dry eye sufferer.

While the tear film operates as a singular entity and all of the layersare important, the lipid layer, which is secreted from the meibomianglands, is of particular significance as it functions to slow theevaporation of the underlying layers and to lubricate the eyelid duringblinking; such slowing of evaporation and lubrication of the eyelidlargely prevent “dry eye syndrome”.

Thus, to summarize, the meibomian glands of mammalian (e.g., human)eyelids secrete oils that prevent evaporation of the tear film andprovide lubrication to the eye and eyelids. These glands can becomeblocked or plugged by various mechanisms leading to so-called “dry eyesyndrome”. While not the only cause, meibomian gland dysfunction is amajor cause of dry eye syndrome. Dry eye syndrome is characterized by ablockage of the meibomian glands, which prevents normal lipid secretionsfrom flowing from the meibomian glands to form the lipid layer of thetear film.

Various treatment modalities have been developed to treat the dry eyecondition, including drops which are intended to replicate and replacethe natural tear film, and pharmaceuticals which are intended tostimulate the tear producing cells. Various heating devices arecommercially available that are designed to assist in unclogging themeibomian glands by “melting” blockages of the meibomian glands. Othertechniques involve manual expression of the glands and manual scrubbingof the eyelid margins.

Eye drops such as REFRESH®, SOOTHE® and SYSTANE® brand eye drops aredesigned to closely replicate the naturally occurring healthy tear film.However, their use and administration is merely a treatment of symptomsand not of the underlying cause. The effect of applying eye drops isshort-lived. Further, the use of drops is generally for an indefinitelength of time and consequently, extended use can become burdensome andcostly.

Since dry eye is exacerbated by eyelid margin debris and bacterialovergrowth, daily eyelid hygiene is often prescribed by physicians andrecommended by health institutions worldwide. This is for the life ofthe patient, because, as mentioned, dry eye is chronic, with no knowncure: unless proper eyelid hygiene is instituted, dry eye syndrome willonly worsen with age.

Herein lie the unsolved problems. No existing eyelid care device enablesself-administered eyelid treatment using a motorized handpiece; allprior art motorized appliances are for clinical use. A second problem isthe risk of patient injury during training of eyelid care professionals,and of lay persons who use a motorized eyelid care appliance forcleaning their own eyelids (“self-administered cleaning” or “SACleaning”) or for cleaning others' eyelids (“second party cleaning” or“SP Cleaning”). The “second party” can be a pet (blepharitis is commonin dogs and cats). A third problem is that all prior art eyelid caredevices with motorized handpieces use unidirectional rotary tools (aka“heads”) that become entangled with hair. A fourth problem is thateyelid care devices with rotary tools cause many patients to flinch whenthe tool first contacts the eyelid margin; such flinching increases therisk of contact by the tool with the cornea, sclera, or other parts ofthe eye and resulting laceration or other injury. A fifth problem is alack of instrumentation of prior art motorized eyelid care devices,which instrumentation (e.g., proximity monitoring, cleaning efficacy)and features (e.g., safety shutoff) would enable safer use of an eyelidcare device as well as data collection and analysis of clinical signsand efficacy of cleaning.

People tend to wash their face, but not their eyelids. Eyelid hygieneshould optimally be performed on a daily basis for maximum efficacy andoptimal hygiene. Currently only manual scrubbing methods with cloths orfingers is available for daily home use, but such manual methods arelike brushing one's teeth with a washcloth. Just as brushing one's teethwith a washcloth does not clean the gingival sulcus or mesio-distalaspects of teeth, an eyelid scrub typically contacts only the anteriorciliary margin and does not clean the entire confluence of the mucosalsurface of the conjunctiva and the cutaneous epithelium. Even thoughdaily eyelid hygiene is critically important for patients with an eyeliddisease, there is typically no compliance by patients for whom SACleaning is ordered by their ophthalmologist. Due to a lack ofalternatives, “baby shampoo” and a washcloth or cotton-tipped swab isoften recommended by ophthalmologists for a patient's SA Cleaning. Thiscurrent “prescription” for eye hygiene has significant non-complianceissues, i.e., patients fail to perform SA Cleaning. For instance, in a“baby shampoo regimen”, the baby shampoo is mixed with warm or hot waterin a prescribed ratio, and the solution is then applied with non-sterileapplicators such as finger tips, cotton tips, or washcloths (typically,unsanitary).

Although commercial “eyelid scrubs” are available in several forms, suchas impregnated, pre-moistened towelettes or pads, or as bottledcleansers applied to a non-sterile applicator pad or to fingertips, sucheyelid scrubs do not improve patient compliance or efficacy. These relyon the individual to perform vigorous back and forth scrubbing of allfour eyelid margins, which is cumbersome, time consuming, sometimespainful, and has uneven results . . . all of which are strongdisincentives to observe a an eyelid cleaning regimen.

Preventive and therapeutic interventions need to be more easilyimplemented at an earlier age, or stage, of dry eye syndrome developmentto decrease the likelihood of chronically scarred and/or dysfunctionalmeibomian glands. Lack of patient compliance is further evidenced by wayof disproportionate commercial sales for eye care products, which showsa clear indication that people simply do not clean their eyelids: incontrast to the US current eyecare market for eye drops (excludingcontact lens solutions) of $1 billion, but eyelid scrubs show less than$8 million in retail sales.

Given existing art methods and devices, it is not surprising that thereis little or no compliance to eyelid hygiene by patients. Related artdescribes an “Eyelid and Anterior Orbit Swab” (to Hamburg, U.S. Pat. No.4,883,454) and various eyelid cleansers, such as U.S. Pat. Nos.8,535,736, 8,449,928, and 8,231,912 (to Gilbard), to clean the eyelids,but these rely solely on manual back and forth motion of a device on theeyelid margin and manual application of a cleanser.

US Published Application No. 20070060988 (by Grenon) discloses an eyelidheater that “melts” plugs that block meibomian glands and expresses themelted plugs through meibomian gland openings on the eyelid margin.Unlike the instant invention, the Grenon device does nothing to actuallyclean the eyelid margin.

U.S. Pat. No. 8,523,928, (Korb and Grenon) describe a system for heatingeyelids. This device is used to liquefy, express and evacuate ductalobstruction, not clean debris and biofilm from the lid margin. The Korbdevice does nothing to actually clean the eyelid margin.

Ophthalmologists presented with a particle (usually a metal particle)embedded in a patient's cornea or sclera (or with the “rust ring” leftby a particle) typically use an ophthalmic burr, such as an Algerbrush(Alger Co., Inc., Lago Vista, Tex.) or Aaron Burr (Bovie Medical Corp.,Purchase N.Y.) to “scrub” the particle or “rust ring” from the cornea orsclera. Ophthalmic burr devices typically have a motorized handpiece anddetachable burrs (burr diameter in the 0.5 mm to 1.0 mm range). At leastone eyelid cleaning device, the BlephEx® device described in USPublished Patent Application Nos. 20140031845, 20140052164, and20140214062, uses a design and unidirectional rotation virtuallyidentical to that of ophthalmic burrs, but with a “sponge head” insteadof a burr. Like ophthalmic burrs, the BlephEx® device drives a head witha full rotary motion and is for use by eyecare professionals. An“eyecare professional” is a person skilled in the art of ocular hygiene,such as ophthalmologists, optometrists, nurses trained in eyecare, andtechnicians trained in eyecare. The BlephEx® handpiece rotates a smallsponge, is guided along the eyelid margin by an eyecare professional,removes scurf and debris, and exfoliates the eyelids. The keydisadvantages of the Blephex® device are its “motorized swab” design,unidirectional spinning (rotating) head (as distinct from an oscillatinghead moving in a reciprocally arcuate path), lack of instrumentation,and lack of safety features. Using an oscillating head to clean eyelidshas significant advantages over existing art eyelid cleaning devices.Oscillating devices tend to be safer than rotary devices; an oscillatinghead does not have the directional “kick” (i.e., start-up torque) of arotating head, so there is less chance of a user losing control of thedevice, e.g., the device jumping out of the user's hand. For thatreason, devices with oscillating heads are easier to control than rotarydevices. An oscillating eyelid care device does not induce a flinchresponse in the subject when the head first contacts an eyelid. Anoscillating head creates less flying debris than a rotary head, makingan oscillating head a better choice for work in an area where excessiveflying debris might be a nuisance, such as near the eye.

The BlephEx® device can only safely be used by an eyecare professionaldue to the ergonomics and dynamics (e.g., “motorized swab” form, flinchinduction, unidirectional rotation) of the device. The stick-like design(i.e., cylindrical handpiece with long, rotating, longitudinally alignedhead) of the BlephEx® device prevents the use of a BlephEx® device forSA Cleaning, i.e., for a patient to use in performing eyelid cleaning onhim/herself. A device with a stick-like design must be used by a secondperson, typically by an eyecare professional.

In eyelid cleaning experiments in a dog model that compared theinvention with (i) manual scrubbing, (ii) the Blephex® device, (iii) aheated, vibrating cup-like device similar to that described in U.S. Pat.No. 8,491,508 (to Smith), and (iv) with motorized cosmetic appliances,such as the Clarisonic Opal® (a discoid, lotion applicator that uses anoscillating, solid silicone head), the results revealed a significantdecrease in eye discharge in eyes treated with the instant invention ascompared to control and to the other devices. In all trials, the eyelidmargins of one eye of a subject were not cleaned, and the eyelid marginsof the other eye were cleaned. When compared to manual lid scrubs theinstant invention removed lid discharge more quickly and thoroughly thanthe manual lid scrub product. The heated, vibrating, cup-like device didnot clean debris from lid margins. Testing of the Blephex® device ondogs had to be discontinued because the Blephex® device induced a strongflinching response when applied to eyelid margins, and dog hair quicklybecame entangled in the head of the Blephex® device, which not onlycaused pain to the dogs but “reeled in” the Blephex® device, whichcaused erratic paths of the device while the head was still spinning.Dogs could not tolerate the vibration of the Clarisonic Opal® on theireyelids, and the Clarisonic Opal® with its smooth silicone head producedno detectable cleaning action. The cleaning results in the dog modelshowed the eyelid care appliance of the invention to be markedlysuperior, based on a close examination of the uncleaned eye versus thecleaned eye, and of cleaned eyes of all subjects. The same solvents andcleansers were used in all trials. The dog model trials were conductedunder a research protocol which was reviewed and approved by theInstitutional Animal Care and Use Committee (IACUC) at the University ofHawaii. The assistance of a licensed veterinarian was obtained. Fourdogs were given one treatment per week with the eyelid care applianceover a three week period. Due to hair entanglement and flinchingresponse, treatment using the Blephex® device was aborted in the dogmodel after two treatments. Treatment using the Clarisonic Opal® wasaborted during the first attempt at treatment, given the strong adversereaction of the dogs to the Clarisonic Opal® device.

Existing powered eyecare devices have heads with a constantunidirectional rotation, which requires that the operator manuallychange the rotational direction (e.g., from clockwise tocounterclockwise) of the head and retrace the path of cleaning to ensureefficient cleaning. An oscillating head provides better removal ofdebris and more uniform results than devices with unidirectional headrotation, which is the reason that oscillating heads are used in poweredtoothbrushes. The head of the driven attachment of a commercial,off-the-shelf powered toothbrush has a “brush head” and such drivenattachment is called a “brush head attachment”. Clinical studies in thedental care literature have shown that powered toothbrushes with anoscillating brush head are significantly better in reducing plaque andgingivitis compared to a manual toothbrush and brushing technique, andalso compared to powered rotary toothbrushes. Just as the oscillatorymovement of a powered toothbrush brush head ensures better cleaning thanmanual scrubbing, because a brush head typically oscillates at about7,000 to 9,000 strokes/minute, the oscillatory movement of a poweredhandpiece coupled to an eyelid care module ensures better cleaning thanmanual scrubbing of the eyelids. The following three publications reportthe comparative advantages of powered, oscillating head, toothbrushes.

-   -   A comparative study of plaque removing efficiency using rotary        electric and manual toothbrushes.

-   Swed Dent J. 1991; 15:229-234.

-   Cochrane Database Syst Rev. 2005; 18(2):CD002281.

-   J Am Dent Assoc. 2003 September; 134(9):1240-4.

-   Manual versus powered toothbrushes: the Cochrane review.

-   Niederman R; ADA Council on Scientific Affairs; ADA Division of    Science; Journal of the American Dental Association.

-   Source: DSM-Forsyth Center for Evidence-Based Dentistry, The Forsyth    Institute, Boston, Mass. 02115, USA. rniederman@forsyth.org    -   CONCLUSIONS: Powered toothbrushes with a rotation-oscillation        action achieve a significant, but modest, reduction in plaque        and gingivitis compared with manual toothbrushes.    -   National Institutes of Health

-   Cochrane Database Syst Rev. 2005 Apr. 18; (2):CD002281.

-   Manual versus powered toothbrushing for oral health.

-   Robinson P G, Deacon S A, Deery C, Heanue M, Walmsley A D,    Worthington H V, Glenny A M, Shaw W C.

-   Source: Department of Dental Public Health, School of Clinical    Dentistry, University of Sheffield, Claremont Crescent, Sheffield,    UK. peter.g.robinson@sheffield.ac.uk    -   CONCLUSIONS: Powered toothbrushes with a rotation oscillation        action reduce plaque and gingivitis more than manual tooth        brushing.    -   Powered/electric toothbrushes compared to manual toothbrushes        for maintaining oral health—Cochrane Report June 2014.

-   Yaacob M, Worthington H V, Deacon S A, Deery C, Walmsley A, Robinson    P G, Glenny A. This article reviews 56 studies published from 1964    to 2011 in which 5068 participants were randomised to receive either    a powered toothbrush or a manual toothbrush. Majority of the studies    included adults, and over 50% of the studies used a type of powered    toothbrush that had an oscillation mode of action (where the brush    head rotates in one direction and then the other, aka reciprocally    arcuate).    -   CONCLUSIONS: The evidence produced shows benefits in using a        powered toothbrush when compared with a manual toothbrush. There        was an 11% reduction in plaque at one to three months of use,        and a 21% reduction in plaque when assessed after three months        of use. For gingivitis, there was a 6% reduction at one to three        months of use and an 11% reduction when assessed after three        months of use.

One advantage of oscillating brush head, powered toothbrushes in generalis their ability to remove a greater amount of plaque in a given periodof time than manual brushes. One study (Preber H, Swed. Dent. J. 1991;15:229-234) found that 75% of dental biofilm was removed in 15 secondswith an oscillating powered toothbrush; the same amount of plaqueremoval required twice as long with a manual brush. The results of morethorough cleaning process with oscillating powered toothbrushes can beextrapolated to eyelid hygiene using an oscillating powered device.However, powered toothbrushes cannot be easily adapted to eyelid care,given the large size of the handpiece, brush head attachment, and brushhead, the stiff bristles on toothbrush brush heads (which would laceratethe eyelid margin, cornea, and sclera if used to clean eyelid margins),and the expense of disposable “necks” (the “neck” is the detachabledistal portion of a powered toothbrush that terminates in anon-removable brush head, which means the entire neck must be discardedwhen the brush head wears, rather that disposal of only the brush head).Because powered toothbrush necks are not easily removed and are used formonths before replacement, the brush heads become unsanitary. Forsanitary eyelid care, the head of a device must be easily replaceableand inexpensive, or durable and autoclavable.

There is need for an eyelid care appliance that enables SA Cleaning,reduces risk of patient injury during training of eyelid careprofessionals, reduces risk of patient injury during SA Cleaning and SPCleaning, provides an oscillating head, provides instrumentation andsafety features that improve efficacy of eyelid care, provides aninexpensive and easily replaceable head (and alternatively, a durableand autoclavable head) and ideally provides an adjustable head angle andoptionally provides control over oscillation frequency and angularsweep.

The eyelid care appliance described and claimed herein solves theproceeding problems by providing, in a preferred embodiment, anoscillating, detachable sponge head, adjustable head angle, an ergonomicpowered handpiece, sensors and other controls and instrumentation (suchas, controls, indicators, displays, video, and/or data transmission),and auxiliary functions (cleanser, solvent, and medicament dispensing,gas and liquid dispensing, heating, and suction) that improveprofessional eyelid care, SA Cleaning, and SP Cleaning.

SUMMARY OF THE INVENTION

The apparatus of a preferred embodiment of the invention comprises apower supply (e.g., battery), motor, detachable head, drive system thatcauses oscillation of the head, controls, instrumentation, and ahousing. “Distal” means herein toward the end of the eyelid careappliance on which the head is mounted. “Proximal” means herein towardthe end of the eyelid care appliance in which the power supply and motorare mounted.

A “spongehead” is preferred for eyelid care, but other materials andconfigurations of heads can be used in the invention, particularly fortreating epidermal areas other than eyelid margins. “Spongehead” means asynthetic sponge adhered to a “sponge mount”. The sponge mount mateswith a “head receiver” that is connected to and driven by a drive systemso that the spongehead mated with the head receiver oscillates when themotor is powered on. A spongehead may be configured in a wide range ofembodiments, some of which embodiments include various types ofbristles, adjustable bristles, combinations of bristles and sponge, andother materials of varying topologies and degrees of abrasiveness.

A preferred embodiment of the eyelid care appliance is an “integral”eyelid care appliance comprising a power supply, motor, drive systemthat transmits motive force from the motor to oscillate a head receiver,motor controls, a proximity system, and proximity annunciator containedin a housing, wherein a spongehead is detachably mated with the headreceiver and protrudes from the housing and oscillates when the motor ispowered on. A drive module (defined below) and an eyelid care module(defined below) are the principal elements contained in the housing. Analternate “two-piece” embodiment comprises a detachable neck that mateswith a handpiece; the handpiece comprises the power supply, motor, andpart of the drive system; the detachable neck comprises the head andremainder of the drive system. In a two-piece embodiment, the componentsof the eyelid care appliance can be distributed in whole or in partbetween the handpiece and the detachable neck, depending upon thecomponent and configuration involved. As used herein, “handpiece” meansthe proximal portion of a two-piece embodiment of the invention, whichproximal portion is gripped by a user.

An alternate “two-piece” embodiment of the eyelid care appliancecomprises a handpiece and a detachable neck, a power supply, motor,proximity annunciator, and motor control being contained in thehandpiece, a head receiver being contained in the detachable neck andconnected to the motor through a drive system with portions of the drivesystem distributed in the detachable neck and in the handpiece and witha coupler at the interface of the handpiece and detachable neck, whichdrive system transmits motive force from the motor to oscillate the headreceiver, wherein a spongehead is detachably mated with the headreceiver, protrudes from the detachable neck, and oscillates when themotor is powered on, and portions of a proximity system are distributedin the detachable neck and in the housing.

In the embodiments of the invention, the power supply (typically areplaceable and/or rechargeable battery) powers a DC motor, and when themotor is powered on, the motor (and drive translator, if the motoroutputs unidirectional rotary motion, which motion is translated tooscillating motion) causes the oscillation of a driveshaft (orequivalent means of transmitting motive force, e.g., in a two-pieceembodiment, an electric motor in a handpiece with magnetic or mechanicalcoupling to a detachable neck). The oscillating driveshaft causes thehead receiver to oscillate, which causes the spongehead mounted in thehead receiver to oscillate. The eyelid care appliance is typicallybattery powered, but can be powered by a power supply connected to anelectrical outlet.

To use the eyelid care appliance claimed herein, a user grips theproximal portion of the appliance, powers on the appliance, and appliesthe oscillating head on the distal end of the appliance, together with asolvent or cleanser, to the eyelid margin to scrub the eyelid margin. Ina preferred embodiment for SA Cleaning and SP Cleaning, the eyelid careappliance comprises a drive module, drive controls and annunciator,eyelid care module with adjustable head angle, proximity sensor,proximity controls and annunciator, and related data channels. Apreferred configuration of proximity sensor and annunciator is a videocamera, a Bluetooth® or similar near field communication channel(Bluetooth, ANT+, WiFi, or other near field communications channel arecollectively called, “NFC”)), and a smartphone or tablet computer withnear field communications capability and display (collectively, “smartdevice”) that is paired with the eyelid care appliance: the video imagefrom the eyelid care appliance is transmitted through the communicationchannel and displayed on the smart device. A user of the eyelid careappliance essentially “flies” the head onto the eyelid margin and movesthe head along the margin. By focusing on the display, the user becomesimmersed in control of the head rather than fearful of poking himself orherself in the eye. The proximity system can evaluate or score userperformance as if the use of the eyelid care appliance were a videogame.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 a: Eyelid Care Appliance, Integral Version, Front Isometric View

FIG. 1 b: Eyelid Care Appliance, Integral Version, Rear Isometric View

FIG. 1 c: Eyelid Care Appliance, Integral Version, Rear View

FIG. 1 d: Eyelid Care Appliance, Integral Version, Cross-section View

FIG. 2 a: Eyelid Care Appliance, Integral Version, Exploded View withSpongehead Detached from Receiver

FIG. 2 b: Eyelid Care Appliance, Integral Version, Front View

FIG. 2 c: Eyelid Care Appliance, Integral Version, Side View

FIG. 3: Eyelid Care Appliance, Integral Version, Exploded View

FIG. 4: Eyelid Care Appliance, Integral Version, LCD Embodiment, FrontIsometric View

FIG. 5: Eyelid Care Appliance, Integral Version, LED Embodiment with LEDLight Ring and Adjustment, Front Isometric View

FIG. 6 a: Eyelid Care Appliance, Integral Version, Suction PumpEmbodiment, Front Isometric View

FIG. 6 b: Eyelid Care Appliance, Integral Version, Suction PumpEmbodiment, Rear Isometric View

FIG. 7 a: Eyelid Care Appliance, Integral Version, Liquid/Gas PumpEmbodiment Front Isometric View

FIG. 7 b: Eyelid Care Appliance, Integral Version, Liquid/Gas PumpEmbodiment Exploded View

FIG. 8 a: Cylindrical Spongehead Front View

FIG. 8 b: Cylindrical Spongehead Side View

FIG. 8 c: Cylindrical Spongehead Isometric View

FIG. 9 a: Concave Spongehead Front View

FIG. 9 b: Concave Spongehead Side View

FIG. 9 c: Concave Spongehead Isometric View

FIG. 10 a: Pointed Spongehead Front View

FIG. 10 b: Pointed Spongehead Side View

FIG. 10 c: Pointed Spongehead Isometric View

FIG. 11 a: Convex Spongehead Front View

FIG. 11 b: Convex Spongehead Side View

FIG. 11 c: Convex Spongehead Isometric View

FIG. 12 a: Bristle Head Front View

FIG. 12 b: Bristle Head Side View

FIG. 12 c: Bristle Head Isometric View

FIG. 13 a: Bristle Spongehead Front View

FIG. 13 b: Bristle Spongehead Side View

FIG. 13 c: Bristle Spongehead Isometric View

FIG. 14 a: Concave Bristle Head Front View

FIG. 14 b: Concave Bristle Head Side View

FIG. 14 c: Concave Bristle Head Isometric View

FIG. 15 a: Convex Bristle Spongehead Front View

FIG. 15 b: Convex Bristle Spongehead Side View

FIG. 15 c: Convex Bristle Spongehead Isometric View

FIG. 16 a: Small, Higher Chamfer Spongehead Front View

FIG. 16 b: Small, Higher Chamfer Spongehead Side View

FIG. 16 c: Reduced Diameter Spongehead Isometric View

FIG. 17 a: Caldera Spongehead Front View

FIG. 17 b: Caldera Spongehead Side View

FIG. 17 c: Caldera Spongehead Isometric View

FIG. 18 a: Eyelid Care Appliance with Video Proximity System

FIG. 18 b: Eyelid Care Appliance with Video Proximity System and NearField Communication Channel to Smart Device

FIG. 18 c: Smart Device Display Showing Video from Eyelid Care ApplianceProvided by Video Proximity System via Near Field Communication Channel

FIG. 19: Eyelid Care Appliance with Adjustable Head Angle and PistolGrip

DRAWING CALLOUTS

-   1: Main Housing-   2: Spongehead-   3: Battery Cover-   4: Housing Cap-   5: Sponge Mount-   6: Head Receiver-   7: DC Motor-   8: AA, Lithium Ion14450, or Equivalently Sized Battery-   9: Battery Clip-   10: Suction Pump Outlet-   11: Printed Circuit Board-   12: Motor Housing-   13: Pinon Gear-   14: Spur Gear Linkage-   15: Keyed Shaft-   16: Drive Housing-   17: Receiver Linkage-   18: Linkage Tee with Spring-   19: Light Pipe and Light Ring-   20: Housing Pin-   21: Linkage Pin-   22: Carrier Pin-   23: Battery Housing-   24: Power Button Over-Molding-   25: Spongehead Sensors-   26: LCD Display-   27: LED Control-   28: Suction Nozzle-   29: Liquid/Gas Nozzle-   30: Liquid/Gas Tubing-   31: Liquid/Gas Pump-   32: Liquid/Gas Tubing-   33: Liquid/Gas Reservoir-   34: Concave Spongehead-   35: Pointed Spongehead-   36: Convex Spongehead-   37: Bristle Head-   38: Bristle Spongehead-   39: Concave Bristle Head-   40: Convex Bristle Spongehead-   41: Small, Higher Chamfer Spongehead-   42: Small, Higher Chamfer Sponge Mount-   43: Conical Spongehead-   44: Video Camera Lens-   45: Cylindrical Sponge-   46: Drive System Adjustment Holes-   47: Adjustable Head

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

The present invention, the eyelid care appliance, is directed to noveldevices and methods effective for restoring and maintaining good eyelidhygiene, e.g., both prophylaxis and therapeutic treatment. The methodsand devices disclosed herein include those for SA Cleaning and SPCleaning, which enable better patient compliance with prescribed eyelidcleaning regimens, esp., daily prophylaxis. The incidence of blepharitisincreases as a function of age. If a person's neurological deteriorationprevents them from performing SA Cleaning, a lay care-giver can performSP Cleaning of such person's eyelids using the eyelid care appliance.These methods involve the easy and safe mechanical cleaning of an eyelidby eyecare professionals in clinical settings and by lay individuals inany location in which manipulation of the individual's eyelids or theeyelids of a second party is safe. “Second party” includes animals,especially household pets, horses, and farm animals. The presentinvention provides improved cleaning of the eyelid margins and meibomiangland orifices, and enables a patient to clean his or her eyelidswithout assistance. The invention solves the technical problems ofimproved eyelid cleaning and training in eyelid cleaning, esp., thetechnical problems in SA Cleaning and SP Cleaning.

“Head” means a spongehead unless otherwise denoted as a brush head,combination sponge and bristle head, or head made with materials otherthan sponge and bristles. The motive action of the driving means istransmitted through from the motor through the drive system to the headreceiver. The eyelid care appliance is always used with a cleanserand/or lubricant that is applied to the sponge of the spongehead and/ordirectly to the eyelids being cleaned. In addition to cleanser and/orlubricants, medicaments can be applied to the spongehead and/or directlyto the eyelids being cleaned. When a user turns on an eyelid careappliance, and applies the oscillating spongehead to an eyelid,oscillation of the spongehead cleans the eyelid margins and meibomiangland orifices of cellular and sebaceous debris. Such cleaning prevents,for an ensuing period, gland obstruction and promotes health of theglands in the eyelid. The oscillation frequency and angular sweep canoptionally be user-selected and implement via printed circuit board <11>control of motor <7>. Oscillation frequency of the head is nominally7,000 to 9,000 strokes/minute and angular sweep of the head is nominally70 degrees (i.e., the head travels 70 degrees forward followed by 70degrees backwards). Higher frequency pulsation (nominally 20,000 to40,000 pulses/min.) can optionally be generated by the motor <11> andfed to the head receiver <6>.

A basic embodiment of the invention comprises a power supply (e.g.,battery), drive module that causes oscillation of a head receiver,detachable spongehead mounted in the head receiver, drive control, and ahousing that contains the preceding elements. The housing has anproximal portion, preferably ergonomic, that is easily gripped by hand.The proximal portion of the housing in this embodiment also containsdrive control (at least on/off, and optionally status LED(s),oscillation frequency, oscillation sweep angle, and timer). A status LEDcan indicate simply power on (if lit), or one or more LEDs canadditionally indicate battery charge level, spongehead oscillationfrequency, and other operational states.

A preferred embodiment of the invention comprises a power supply (e.g.,battery), drive module that causes oscillation of a head receiver,detachable spongehead mounted in the head receiver, drive control andannunciator, proximity system, and a housing that contains the precedingelements. The housing has an proximal portion, preferably ergonomic,that is easily gripped by hand. The proximal portion of the housing inthis embodiment also contains drive control (described above) andproximity control and annunciator. The details of the proximity system,control, and annunciator depend upon the configuration of the proximitysystem. In a video proximity system, the control is at least on/off (andoptionally typical video controls, such as manual or auto iris, andgain) and the annunciator is preferably a mobile display linked to thevideo camera by NFC. In this embodiment, proximity system control ispreferably performed through one or more software applications (“smartapps”) running on the smart device, and would enable recording video ofthe eyelid cleaning in the memory of the smart device or of the eyelidcare appliance. Proximity system settings performed by smart apps or byapplications running on the printed circuit board <11> can include thegeneration of audible tones that reflect distance between the spongeheadand the closest surface and optionally the second closest surface to thespongehead (typically the eyelid margin is closest and the cornea orsclera is second closest surface), colors or icons on the smart devicedisplay that indicate distance, or the generation of a glideslopedisplay on the smart device that guides a user in landing the spongeheadon an eyelid margin. Preferably, one or more lights (e.g., LEDs) on thehousing project light in front of the spongehead in video-equippedembodiments of the invention. The output of the proximity systemsoftware can include the distance between spongehead and eyelid, thedistance between eyelid and eyeball, the battery level, the spongeheadoscillation frequency, and other data to assist the user; such outputcan be displayed on the smart device, as shown in FIG. 18 c. Theproximity system can evaluate or score user performance as if the use ofthe eyelid care appliance were a video game. This embodiment is calledthe “simple proximity embodiment” of the invention. Alternativeembodiments include a video display (typically, an LCD) mounted on orintegral with the eyelid care appliance, projected video, or a videogoggle. A video-based proximity system also provides magnification ofthe treated area and documentation of the progress, and thus makes iteasier to learn to use the eyelid care appliance and to visually confirmcleanliness of treatment area.

A “spongehead” is preferred for eyelid care, but other materials andconfigurations of heads can be used in the invention, particularly fortreating areas other than eyelid margins. “Spongehead” means a syntheticsponge in a disc, cylindrical, globular, and other shape that is adheredto a “sponge mount”. A spongehead of the invention comprises (i) a solidsponge mount with a male or female portion (preferably a male matingportion, such as a post) that mates with a “head receiver” (preferablywith a female mating portion, such as a socket) and (ii) a sponge (orother material adapted for cleaning eyelid margins or other areas)selected for use for cleaning a target surface, such as eyelid margins.Key selection factors for the sponge material are: surface topology,elasticity, shape memory, degree of smoothness, level of porosity, andhydrophilic nature of the sponge. Material selection determines whetherthe spongehead is inexpensive, or durable and autoclavable. A spongemount mates with a head receiver that is connected to and driven by thedrive system so that the spongehead mated with the head receiveroscillates when the motor is powered on. Friction between the post andsocket in the sponge mount/head receiver interface are typically morethan adequate to keep the spongehead firmly affixed to the headreceiver, but still removable for replacement of the spongehead.Alternatively, a weak adhesive can be applied, or a physical detent usedin the plug and socket, to more firmly retain the spongehead in the headreceiver, yet permit removal of the spongehead without tools. The spongemount and head receiver are typically made of a plastic selected towithstand rapid oscillation and devoid of small cavities that can becolonized by bacteria. A post can have any shape that prevents rotationor slippage of the sponge mount when the sponge mount is mated with thehead receiver. The post shape is preferably a polygonal shape, such as ahexagon, triangle, rectangle, or star-shape.

The sponge material, porosity, shape, and other parameters are selectedbased on treatment objectives, e.g., maintaining eyelid health, treatingeyelid conditions and diseases, dermabrasion, polishing, etc. Spongematerials may be low-density polyether, polyvinyl alcohol (“PVA”, whichis highly absorbent), polyester (almost as absorbent as PVA, but moredurable and has larger pores), and other polymers. A spongehead can havevarious surface textures, topologies, porosities, permeabililties,dimensions, inlet (e.g., suction) channels, and outlet (e.g.,dispensing) channels. The sponges of spongeheads can be pre-impregnatedwith topical pharmacologic or cleansing agents to better facilitateapplication and efficacy of said agents. Alternatively, topical agentscan be applied to the sponge before applying the head to an eyelid, orcan be applied using a reservoir-equipped embodiment of the invention.

The sponge used in the invention is preferably sterile and can be easilyreplaced. The spongehead is sterilized and distributed to users inpackaging that maintain sterility. Sterility is desired since aspongehead is used to clean eyelids and in close proximity to the corneaand other exposed parts of the eye, and in other embodiments is used indebridement and wound treatment. A spongehead can be easily replaced bypulling it off the head receiver. Periodic replacement of a disposablespongehead is typically daily in a home use setting (i.e., for SACleaning), or for each patient in a clinical setting.

Alternative embodiments of the instant invention comprise one or more ofthe following elements: (i) illumination source(s) with on/off andoptionally with light intensity control, (ii) one or more refillablereservoirs, pumps, and outlet channels for solvent, cleanser,medicament, and other liquids, powders, and gases (the gases may beheated, cooled, or room temperature and may be used to create an aerosolfrom a liquid or powder), (iii) means of metering and application ofliquids, powders (and other solids), and gases, (iv) a suction pump thatcreates suction in or near the spongehead to remove debris, cleanser,and other matter from a surface being cleaned or treated, (v) sensorsand optionally processors to assay the distance from head to targetarea, materials in target area, and/or materials in suction wastestream,(vi) indicators (visual and aural) and displays, (vii) video camera, and(viii) data communication channels (wired and/or wireless). The hardwareand software used to perform an assay may be located in the handpiece orlocated remotely and linked with the eyelid care appliance by NFC. Ahead can also comprise bristles, typically very small diameter bristles,alone on in combination with a sponge. In some spongehead embodiments,the bristles terminate very close to the surface of a spongehead.Refilling a reservoir is performed by connecting a liquid, gas, orpowder source to an inlet connector on the housing in communication withthe reservoir. Alternatively, a reservoir can be removed from thehousing for refilling. An eyelid care appliance can comprise one or morereservoirs, reservoir inlet connectors, pumps, output tubing, andnozzles for dispensing solvent, cleanser, medicament, and other liquids,powders, and gases. Configurations with two reservoirs and associatedpumps and tubing can be filled with agents that create heat whencombined; when such agents are dispensed and combine on the eyelidsurface, the eyelid surface is heated, thereby helping to “melt”blockages of meibomian glands posterior to the anterior surface or aneyelid.

A preferred embodiment further comprises one or more reservoirs,reservoir inlet connectors, pumps, output tubing, and nozzles fordispensing liquids selected from the group comprising cleaning agents,Betadine, antiseptics, antimicrobials, anti-inflammatories, anesthetics,saline solution, water, solvents, taggants, stains, pharmaceuticals,nutriceuticals, and monoclonal antibodies. Another preferred embodimentfurther comprises one or more reservoirs, reservoir inlet connectors,housing inlets, pumps, output tubing, and nozzles for dispensing gases,wherein optionally the gases are heated or cooled by a thermal device inthe output tubing and can optionally be used to create an aerosol from aliquid or powder sourced from a different reservoir, and can optionallybe used to create an aerosol from a liquid or powder in such differentreservoir. The gas can be ambient air fed to the pump from an inlet inthe housing rather than from a reservoir.

The preferred embodiment is an “integral” eyelid care appliance in whichall elements of a given configuration are contained in a single housing;a drive module (defined below) and an eyelid care module (defined below)are the principal elements contained in the housing. A preferredembodiment comprises a power supply, motor, drive system that transmitsmotive force from the motor to oscillate a head receiver, motorcontrols, a proximity system, and proximity annunciator contained in ahousing, wherein a spongehead is detachably mated with the head receiverand protrudes from the housing and oscillates when the motor is poweredon. An alternate “two-piece” embodiment comprises a handpiece and adetachable neck, a power supply, motor, proximity annunciator, and motorcontrol being contained in the handpiece, a head receiver beingcontained in the detachable neck and connected to the motor through adrive system with portions of the drive system distributed in thedetachable neck and in the handpiece and with a coupler at the interfaceof the handpiece and detachable neck, which drive system transmitsmotive force from the motor to oscillate the head receiver, wherein aspongehead is detachably mated with the head receiver, protrudes fromthe detachable neck, and oscillates when the motor is powered on. In atwo-piece embodiment, each of the components recited in items (i) to(viii) above can be distributed in whole or in part between thehandpiece and the detachable neck, depending upon the component andconfiguration involved. In two-piece embodiments of the invention, thedetachable neck comprises an eyelid care module; the neck is detachablymated with a handpiece containing a drive module and the interfacebetween the detachable neck and the handpiece includes a drive systeminterface (e.g., a mechanical coupling such as a male shaft mating witha female receiver, wherein the shaft and receiver have matinggeometries, such as a D-shape, triangle shape, star shape, etc., or amagnetic coupling).

In all embodiments of the invention, a power supply (typically areplaceable and/or rechargeable battery) powers a DC motor, and when themotor is powered on, the motor (and drive translator, if the motoroutputs unidirectional rotary motion) causes the oscillation of adriveshaft (or equivalent means of transmitting motive force, e.g., in atwo-piece embodiment, an electric motor with magnetic or mechanicalcoupling to a detachable neck). The oscillating driveshaft causes thehead receiver to oscillate, which causes the spongehead mounted in thehead receiver to oscillate. The eyelid care appliance is typicallybattery powered, but can be powered by a power supply connected to anelectrical outlet.

A “drive module” comprises a power supply, motor, on/off control, driveshaft, and related transmission elements. If the motor outputsunidirectional rotary motion, such unidirectional rotary motion istranslated so that the driveshaft causes the head to oscillate. Thecombination of the motor, driveshaft, and related transmission elements(such as a drive translator) is called a “drive system”. A well-knowndrive translator has a motor-driven driveshaft with pinion gear drivinga geared disc or cam; an eccentric follower link on the geared disc orcam causes a shaft linked to the geared disc or cam to oscillate. Thedrive system couples the motive force of the motor to the head.

An “eyelid care module” comprises at least a spongehead, head receiver,and associated drive system. Integral and two-piece embodiments of theinvention can be configured to provide the same functionality;functionality of two-piece embodiments may be limited by thefunctionality of the handpiece, however. For instance, a detachable neck(containing an eyelid care module) that mates with a generic poweredhandpiece, e.g., an electric toothbrush handpiece, would have to haveadditional functionality configured in the detachable neck.

As shown in FIGS. 1 a to 1 d, and 2 a to 2 c, a basic embodiment of theinvention comprises a drive module and an eyelid care module in asingle, “integral” housing <1>. A spongehead <2> comprising a sponge<45> and a sponge mount <5> is mounted on the distal end of theappliance. A sponge <45> of a given geometry (described below) ispermanently adhered to a sponge mount <5>.

In embodiments in which the head angle (the angle between the axis ofoscillation of the spongehead and the longitudinal axis of the housing<1>) is non-adjustable, the head angle is fixed between zero and 90degrees. In embodiments in which the head angle is adjustable (see FIG.19), the head receiver pivots in a frame that either has detents atgiven head angles (e.g., 30 degrees, 45 degrees, 60 degrees, etc.) orhas a locking mechanism that holds the head at a user selectable headangle. The spongehead can also be locked in place at each detentposition. The preferable head angle is typically in the range from 20degrees to 80 degrees, and preferably in the range of 45 to 65 degrees.The primary factor in selecting the head angle is to facilitate SACleaning and to accommodate user comfort in holding and manipulating theeyelid care appliance. Both integral and two-piece embodiments of theinvention can have a head receiver with adjustable head angle(“adjustable head receiver”). Embodiments of the eyelid care attachmentwith adjustable head receivers can use a ball joint, U-joint, or gearedjoint as part of the drive system. An extension shaft with compatiblemale and female ends can be inserted between the sponge mount and thehead receiver, just like using an extension shaft in a socket wrenchset.

An alternative configuration of the head receiver and drive systemplaces an adjustable head receiver at the distal tip of the eyelid careappliance, and the head angle can be adjusted through a range up to 180degrees (i.e., +90 degree head angle to −90 degree head angle) and fixedat a given head angle through detents and/or locking mechanism. Suchexpanded range of head angles avoids the need to invert the eyelid careappliance when cleaning the upper eyelid margins, and also keeps theon/off button in the same location within the user's grip. An adjustablehead receiver embodiment of the eyelid care appliance facilitatesdifferent angulations of treatment and therapy. A preferred adjustablehead receiver embodiment has detents in the head receiver at specificangulations, e.g., 45, 90, 135 and 180 degrees of head angle. Thespongehead can be locked in place at each detent position. A secondpreferred adjustable head receiver embodiment can be locked in place,e.g., by a clamping means, at any angulation with the range of headangulation.

As shown in FIG. 1 d, a battery <8> is fitted in a battery compartmentin the proximal end of the main housing <1>. Battery access is through abattery door <3>. Housing cap <4> seals the proximal end. A DC motor <7>with a pinion gear <13> on its output shaft drives a spur gear linkage<14> that converts rotary motion of the pinion gear <13> to oscillating(reciprocally arcuate) motion and drives a keyed shaft <15>. The keyedshaft <15> causes the head receiver <6> to oscillate. The sponge mount<5> with affixed sponge fits firmly (either by friction or by detent)into a head receiver <6>, and oscillates in a fixed relationship to thehead receiver <6>. If a rechargeable battery is used as the power sourcein the handpiece, a means of recharging (e.g., inductive, or conductiveterminals) the battery can be incorporated into a stand or holder forthe device of the invention; alternatively, the battery can be removethrough battery cover <3> for recharging in a charging dock.

In a preferred embodiment for SA Cleaning and SP Cleaning, the eyelidcare appliance comprises a drive module, drive controls and annunciator,eyelid care module with adjustable head angle, proximity sensor,proximity controls and annunciator, and related data channels. Theproximity sensor determines or depicts the distance between the surfaceof the head and the eyelid margin. The proximity annunciator can be alight or a light array, a display, a generated voice, or tactile. Apreferred configuration, as shown in FIGS. 18 a, 18 b, and 18 c, ofproximity sensor and annunciator is a video camera <44> linked to asmartphone or tablet computer with display (collectively, “smartdevice”) that is paired with the eyelid care appliance by NFC: the videoimage from the eyelid care appliance is transmitted through NFC anddisplayed on the smart device. The video camera <44> is preferably on asmall gooseneck that can slide within a yoke, or be detached from theyoke to change the point of view of the video camera. As shown in FIG.18 c, a user of the eyelid care appliance with video proximity system“lands” the spongehead on the eyelid margin and moves the spongeheadalong the eyelid margin during cleaning of a margin. This preferredembodiment comprises a power supply, motor, drive system that transmitsmotive force from the motor to oscillate a head receiver, motorcontrols, a proximity system, and proximity annunciator contained in ahousing, wherein a spongehead is detachably mated with the head receiverand protrudes from the housing and oscillates when the motor is poweredon, wherein the proximity system is a video camera with lens mountednear the spongehead and in near field communication with a smart device,and wherein the video output from the video camera is displayed on thesmart device. By focusing on the smart device display linked to theeyelid care appliance by a near field communication channel, the userbecomes immersed in control of the spongehead rather than fearful ofpoking himself or herself in the eye. The proximity system can evaluateor score user performance as if the use of the eyelid care appliancewere a video game.

As shown in FIG. 2 a, a sponge mount <5>, bearing a sponge <45>, isdetachably (aka removably) affixed to the head receiver <6>. The spongemount <5> preferably has a polygonal post is inserted into a socket onthe head receiver <6>. The head receiver <6> is linked to the distal endof the drive system and driven in an oscillating motion by the drivesystem. The post/socket fastening system facilitates the easy attachmentand removal of a spongehead. Disposable spongeheads are inexpensive,disposable, yet can be distributed sterile in packages. Multiple usespongeheads, for specific clinical procedures, are durable enough towithstand being autoclaved or otherwise repeatedly sterilized. Thedevice of the invention has several alternative embodiments with fluidreservoirs of different types. The simplest design equipped with a fluidreservoir uses a head in which the sponge has a recessed tip (called a“concave spongehead”, shown in FIGS. 9 a-9 c, with a concave sponge<34>), which allows for liquids, gels and ointments deposited in therecess of the tip to be applied to the eyelid surface when the device ofthe invention is in use. Another embodiment of the device of theinvention, as shown in FIGS. 7 a and 7 b, features a fluid reservoir<33> and a pump <31> and supply channel <30, 32> that connect thereservoir to a nozzle <29> near (or alternatively, ported through) thespongehead <2>. Embodiments of the eyelid care appliance with reservoirsare equipped with dispensing controls and associated sensors, valves,and optional data channels that report sensor output and valve status.Controls in the eyelid care appliance are activated by buttons on thehousing (or handpiece) and implemented by a processor on a printedcircuit board (<11> in FIG. 3) Liquids, gels, ointments, cleansers,solvents, gases, powders or other fluid or fluidizable medicaments areplaced in the reservoir for delivery to or near the spongehead throughthe supply channel. The pump <31> forces the contents of the reservoirinto or near the spongehead for dispersal on the eyelid being cleaned ortreated. Dispensed fluids can include cleaning agents, Betadine,antiseptics, antimicrobials, anti-inflammatories, anesthetics, salinesolution, water, solvents, taggants, stains, pharmaceuticals,nutriceuticals, and monoclonal antibodies. Reservoir and pump equippedembodiments can include a means to fluidize a powder or liquid into anaerosol for dispersal. An embodiment equipped to disperse liquids orgases can be equipped with a heater to heat the liquid or gas beforedispersal near or through the spongehead. Another embodiment equipped todisperse gases can use ambient air, preferably filtered by a filter inthe air intake, rather than gas in a reservoir; this embodiment isparticularly useful for administration of aerosols, since a separate gasreservoir is not needed. Heated fluids (liquid, gas, or air) can be usedto warm the surface of the eyelid to “melt” blockages in meibomianglands, and the spongehead (oscillating or inactive) can be used tomassage blockage areas. A “massage” spongehead would preferably have aconvex sponge <35> (FIG. 10 b) or conical sponge <43> (FIG. 17 b).

The drive module of an eyelid care appliance is either (i) in the samehousing <1> as an eyelid care module, or (ii) interfaced with adetachable neck and a coupler, to transmit oscillating motion to thehead receiver. A two-piece appliance can have all the structuralelements and functionality of an integral eyelid care appliance otherthan the neck being detachable from a handpiece (e.g., a battery poweredtoothbrush).

As shown in FIG. 3, a battery <8> is fitted in a battery housing <23> inthe proximal end of the main housing <1>. Battery access is through abattery door <3>. The battery contacts battery clips <9> to supply DCmotor <7> with electrical power with power controlled via printedcircuit board <11> and a power button that is surrounded by a powerbutton over-molding <24>. Housing cap <4> seals the proximal end. A DCmotor <7> with a pinion gear <13> on its output shaft drives a spur gearlinkage <14> that converts rotary motion of the pinion gear <13> tooscillating (reciprocally arcuate) motion and drives a keyed shaft <15>.Pinion gear <13>, spur gear linkage <14> and keyed shaft <15> fit withina drive housing <16>. Receiver linkage <17> transmits the oscillatingmotion of the keyed shaft <15> through a linkage tee with spring <18> tothe head receiver <6>. Housing pin <20>, linkage pin <21>, and carrierpin <22> join the assembly of receiver linkage <17>, linkage tee withspring <18>, and head receiver <6>. Drive system adjustment holes <46>permit adjustment of the pins for proper orientation of head receiver<6>. The sponge mount <5> with affixed sponge <45> fits firmly (eitherby friction or by detent) into a head receiver <6>, and oscillates in afixed relationship to the head receiver <6>. Light pipe and light ring<19> provide light in the direction of the spongehead post axis from anLED mounted on and controlled by printed circuit board <11>.Alternatively, power controlled by printed circuit board <11> can beprovided to LEDs near the head receiver <6> or to LEDs on the distalportion of the eyelid care appliance. If a rechargeable battery is usedas the power source in the handpiece, a battery charger (e.g.,inductive, or conductive terminals) can be incorporated into a stand orholder for the device of the invention; alternatively, the battery canbe removed through battery cover <3> for recharging in a charging dock.One or more lighting LEDs can project light in front of the spongehead,thereby providing adequate illumination for the user and/or a videocamera.

As shown in FIG. 19, alternative embodiments of the eyelid careappliance include designs in which the appliance has a “pistol grip”proximal portion and adjustable head angle <47>. Other alternativeembodiments include (i) a “pistol grip” handpiece, (ii) versions inwhich the eyelid care appliance mounted on or integral with a glove, or(iii) in which the eyelid care appliance is mounted on a handstrap. Thepistol grip integral embodiments can include a distal pivot so that theangle between the grip portion and the distal portion containing theeyelid care module (or in two-piece embodiments, the angle between thehandpiece and the detachable neck) can be selected by the user andmaintained by detents in the pivot mechanism or by a lock.

As shown in FIG. 4 (showing sensor <25>), FIG. 5 (showing LED control<27>), FIG. 6 a (showing suction nozzle <28>), 6 b (showing suction pumpoutlet <10>), and FIGS. 7 a and 7 b (showing liquid/gas nozzle <29>,liquid/gas tubing <30, 32>, liquid/gas pump <31>, and liquid/gasreservoir <33>), various sensors, inlets, and outlets can be configuredin the eyelid care appliance. FIG. 4 shows a suction pump with a suctioninlet near the spongehead and an suction pump outlet <10> in thehousing, wherein the suction inlet removes debris and liquids from theeyelid margin and expels such debris and liquids as a wastestreamthrough the outlet <10> in the housing. The outlet <10> can beconfigured with a connector and mated with connectorized tubing thatroutes the wastestream into a collection reservoir, diagnostic apparatusinput, or a drain. A preferred embodiment further comprises a suctionpump with a suction inlet near the spongehead and an outlet in thehousing, wherein the suction inlet removes debris and liquids from theeyelid margin and expels such debris and liquids as a wastestreamthrough an outlet in the housing. In embodiments with a suction pump,the wastestream input or output of the suction pump can be examined by avideo camera, flow cytometer, or other sensor and associated software todetect and report the contents of the wastestream, e.g., particle count,chemical profile (before cleaning, during cleaning, after cleaning, esp.of tear film), presence of bacteria, etc. Stains, monoclonal antibodies,and other taggants can be administered and monitored as part ofwastestream assays. A preferred embodiment further comprises a suctionpump with a suction inlet near the spongehead and an outlet in thehousing, wherein the suction inlet removes debris and liquids from theeyelid margin and expels such debris and liquids as a wastestreamthrough an outlet in the housing and wherein the wastestream input oroutput of the suction pump is examined by a video camera, flowcytometer, or other sensor and associated software to detect and reportthe contents of the wastestream. This embodiment provides the firstreal-time reporting of tear film profile, the efficacy of eyelidcleaning, cleanser concentration, medicament concentration, etc., andprovides a very important new tool in training, in diagnosis, and inmonitoring therapeutic interventions.

As shown in FIGS. 8 a through 17 c, the sponge or other material mountedon a spongehead for contact with a skin or wound surface can havevarious constituent materials and geometries adapted to the cleaning,therapeutic application, or assay to be conducted. Exemplary materialsand geometries are concave spongehead <34>, pointed spongehead <35>,convex spongehead <36>, bristle head <37>, bristle spongehead <38>,concave bristle head <39>, convex bristle spongehead <40>, small, higherchamfer spongehead <41>, small, higher chamfer sponge mount <42>, andconical spongehead <43>.

Software applications and sensors used with embodiments of the eyelidcare appliance (including embodiments with a system on a chip within theeyelid care appliance or with a smart device linked by NFC to the eyelidcare appliance) can detect and report: how often and for how long onehas scrubbed an area, battery condition, how much pressure is applied atthe spongehead, patency of the meibomian glands, health of the eyelidmargin, etc. A video and and/or sensor equipped eyelid care appliancecan also provide images and/or assay reports, respectively, of otherbody surfaces, e.g., skin lesions, wounds. The software applications canrun on a computer integral with the eyelid care appliance, on a remotedevice, or on networked devices, including the eyelid care appliance asa client in a network.

Embodiments of the invention with lighting and a video proximity systemcan be equipped with band-limited light sources, either by selection ofLED emitters and/or by filtering, and with multispectral image analysissoftware. Such an embodiment further comprises one or more band-limitedlight sources that project light in front of the spongehead, wherein theproximity system is a video camera with lens mounted near the spongeheadand in near field communication with a smart device, wherein the videooutput from the video camera is fed to multispectral image analysissoftware in the smart device or in the appliance, and the output of themultispectral image analysis software is displayed on the smart device.Using multispectral image analysis well known in the art, andimplemented in software applications running on an integral processor oron a smart device with an NFC link to the eyelid care appliance,provides a non-invasive, real-time method of determining the health ofan eyelid (or other skin area).

Although a sponge cover can be made to fit over an existing brush headof a powered toothbrush, and a “sponge cover” is less expensive than aspongehead, the safety of use of a sponge cover depends upon howsecurely the sponge cover is attached or adhered to the brush head andthe size of the brush head. Moreover, electric toothbrush brush headsare generally far too big, and the handpiece too cumbersome, for use ineyelid care.

In addition to routine eyelid cleaning, SA Cleaning, and SP Cleaning,the invention may also be used to clean other areas and types of tissuewhere, or in other applications in which, a surface needs to bethoroughly cleaned, such as:

-   -   a. Pre-operative eyelid cleaning for ocular or peri-ocular        surgery with cleansing/antimicrobial solutions (including        povodine/iodine solution).    -   b. Application of dermatologic creams for acne to be applied        directly to the blemish or other skin area. This will allow a        more precise placement of the medication so as not to dry out        surrounding skin. Also, the oscillating sponge will allow a more        even and thorough application of the product. The sponge can be        pre-loaded with an appropriate amount of medication.        Sensor-equipped embodiment of the invention can provide assay        reports of the skin area.    -   c. Application of eyelash lengthening therapies, e.g., the        Latisse® (Allergan Corp.) therapy currently recommends the use        of small applicator brushes to apply the product. This demands        very exact eye-hand coordination. Use of the invention,        preferably a video-equipped embodiment, would allow easier        application with perhaps better coverage of the lashes.    -   d. Wound cleaning and debridement. Wound cleaning and        debridement can be challenging by existing manual techniques.        This device can be used to thoroughly and precisely clean wounds        and removal foreign material and dead tissue from a wound.        Sensor-equipped embodiment of the invention can provide assay        reports of the skin area.    -   e. To apply a pharmaceutical to a lesion. Sensor-equipped        embodiment of the invention can provide assay reports of the        skin area.    -   f. Veterinary use for cleaning eyelids or other areas on animals        that require a small cleaning device. Sensor-equipped embodiment        of the invention can provide assay reports of the skin area.

The eyelid care appliance can be made in various sizes, e.g., pediatricand adult. An eyelid care appliance can be made in various sizes ofdrive module, e.g., different glove sizes, different pistol grip sizes,and in different sizes of spongehead, e.g., pediatric and adult.Two-piece embodiments of the eyelid care appliance can be made with astandard interface between detachable neck and handpiece so thatdifferent sizes of detachable necks can be mated with different sizes ofhandpieces. Any embodiment of the eyelid care appliance can include anaccelerometer that detects that the appliance has been dropped and thatcauses the motor to be powered off Any embodiment of the eyelid careappliance can also use NFC to report its location to a smart device.

Alternative embodiments of the invention designed to care for bodysurfaces other than eyelids are called herein “surface care devices”and, like eyelid care appliances, comprise a drive module and an eyelidcare module, and include the alternative embodiments described above(e.g., proximity systems, fluid and fluidized agent dispersal systems,suction systems, NFC links to smart devices, etc.). Spongeheads ofvarious diameters and topologies are tailored to the skin area to betreated, e.g., a large concave spongehead to treat elbows, a smallconcave spongehead to treat fingertips. Surface care devices alsoinclude wound care devices adapted for various types of wounds to becleaned or otherwise analyzed or treated using a surface care device;one embodiment of a surface care device for wounds is a mechanicaldebridement device.

A surface care appliance can be used for pre-operative scrubbing ofsmall areas of skin before surgery, in particular for scrubbing ofeyelid margins. Pre-operative scrubbing is currently done manually withswabs and sponges.

An alternative embodiment of the invention can be configured by choiceof spongehead to clean makeup off eyelids; a sterile spongehead could bemounted for each use. Current methods of using moistened towellettes orcotton balls may not thoroughly clean eyelids of all residual makeup.This device could be used either primarily or as an adjunct to the abovedescribed methods to more thoroughly and rapidly remove eye makeup.

An alternative embodiment of the invention can be configured by choiceof spongehead to clean, buff or polish nails and for cuticle care.Current techniques use reusable, manual devices which are ofquestionable sterility. This embodiment would provide a quicker, moreefficient way to perform nail and cuticle tasks, and a sterilespongehead could be mounted for each use.

To generalize the preceding description, like eyelid care appliances,surface care devices of the invention are of two types: (1) an integralappliance, with an eyelid care module and drive module within a singlehousing, optionally with a pivoted grip, or (2) a two-piece appliance,comprising a handpiece and detachable neck, optionally with a pivotedhandpiece. Embodiments of surface care devices, e.g., for skin care andwound care, are adapted for areas to be cleaned or otherwise analyzed ortreated.

Further modifications will also suggest themselves to those skilled inthis art, and such are considered to fall within the spirit and scope ofthe invention as defined in the appended claims.

We claim:
 1. An eyelid care appliance comprising a power supply, motor,drive system that transmits motive force from the motor to oscillate ahead receiver, motor controls, a proximity system, and proximityannunciator contained in a housing, wherein a spongehead is detachablymated with the head receiver and protrudes from the housing andoscillates when the motor is powered on.
 2. An eyelid care appliancecomprising a power supply, motor, drive system that transmits motiveforce from the motor to oscillate a head receiver, motor controls, aproximity system, and proximity annunciator contained in a housing,wherein a spongehead is detachably mated with the head receiver andprotrudes from the housing and oscillates when the motor is powered on,wherein the proximity system is a video camera with lens mounted nearthe spongehead and in near field communication with a smart device, andwherein the video output from the video camera is displayed on the smartdevice.
 3. An eyelid care appliance comprising handpiece and adetachable neck, a power supply, motor, proximity annunciator, and motorcontrol being contained in the handpiece, a head receiver beingcontained in the detachable neck and connected to the motor through adrive system with portions of the drive system distributed in thedetachable neck and in the handpiece and with a coupler at the interfaceof the handpiece and detachable neck, which drive system transmitsmotive force from the motor to oscillate the head receiver, wherein aspongehead is detachably mated with the head receiver, protrudes fromthe detachable neck, and oscillates when the motor is powered on, andportions of a proximity system are distributed in the detachable neckand in the housing.
 4. The eyelid care appliance of claim 1, 2, or 3,wherein the head receiver is an adjustable head receiver.
 5. The eyelidcare appliance of claim 1 or 2, wherein the proximity system annunciatorfurther comprises the generation of audible tones that reflect distancebetween the spongehead and the closest surface and optionally the secondclosest surface to the spongehead.
 6. The eyelid care appliance of claim1 or 2, wherein the proximity system is a video camera with lens mountednear the spongehead and in near field communication with a smart device,wherein the video output from the video camera is displayed on the smartdevice, and wherein the proximity system generates a glideslope displayon the smart device that guides a user in landing the spongehead on aneyelid margin, and optionally one or more lights on the housing projectlight in front of the spongehead.
 7. The eyelid care appliance of claim1 or 2, further comprising one or more reservoirs, reservoir inletconnectors, pumps, output tubing, and nozzles for dispensing liquidsselected from the group comprising cleaning agents, Betadine,antiseptics, antimicrobials, anti-inflammatories, anesthetics, salinesolution, water, solvents, taggants, stains, pharmaceuticals,nutriceuticals, and monoclonal antibodies.
 8. The eyelid care applianceof claim 1 or 2, further comprising one or more reservoirs, reservoirinlet connectors, housing inlets, pumps, output tubing, and nozzles fordispensing gases, wherein optionally the gases are heated or cooled by athermal device in the output tubing and can optionally be used to createan aerosol from a liquid or powder in a different reservoir.
 9. Theeyelid care appliance of claim 1 or 2, further comprising a suction pumpwith a suction inlet near the spongehead and an outlet in the housing,wherein the suction inlet removes debris and liquids from the eyelidmargin and expels such debris and liquids as a wastestream through anoutlet in the housing.
 10. The eyelid care appliance of claim 1 or 2,further comprising a suction pump with a suction inlet near thespongehead and an outlet in the housing, wherein the suction inletremoves debris and liquids from the eyelid margin and expels such debrisand liquids as a wastestream through an outlet in the housing andwherein the wastestream input or output of the suction pump is examinedby a video camera, flow cytometer, or other sensor and associatedsoftware to detect and report the contents of the wastestream.
 11. Theeyelid care appliance of claim 1 or 2, further comprising one or moreband-limited light sources that project light in front of thespongehead, wherein the proximity system is a video camera with lensmounted near the spongehead and in near field communication with a smartdevice, wherein the video output from the video camera is fed tomultispectral image analysis software in the smart device or in theappliance, and the output of the multispectral image analysis softwareis displayed on the smart device.